Neo Vision Co. Ltd
Active in EUDAMEDSouth Koreafrom SRN EUDAMED FDA SRN KR-MF-000037952
- Devices
- 4
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
- Authorised rep.
- CMC Medical Devices & Drugs SLES
What Neo Vision Co. Ltd makes
NEO Vision Co. Ltd manufactures intraocular lenses (IOLs) under the NEO PLUS GOLD and NEO COSMO brands, designed for cataract surgery and refractive correction. These devices include multifocal and toric IOLs to address presbyopia, astigmatism, and other vision impairments. The portfolio also includes specialized IOLs for premium vision restoration, such as extended depth of focus and blue light filtration technologies.
The company’s devices are classified as Class IIa and Class IIb under EU regulations, with listings maintained in the EUDAMED database. These classifications reflect moderate to high-risk medical devices requiring conformity assessment procedures before market placement. The manufacturer is based in South Korea and adheres to regulatory frameworks applicable to its listed devices in the European Union.
Catalogue
MAXLOOK 60ml Ref 185287.8
CE MDD EUDAMEDMAXLOOK 360ml Ref 185286.1
CE MDD EUDAMED- CE MDD EUDAMED
- CE MDD 510(k) EUDAMED510(k)
Company details
- EUDAMED SRN
- KR-MF-000037952
- EUDAMED status
- Active
- EUDAMED registered name
- NEO VISION CO. LTD
- EUDAMED abbreviated name
- Neo Vision
- Registered address
- Heungdeokjungang-ro, Giheung-gu, Yongin-si, Gyeonggi-do 120 U-TOWER 17th floor, 16950, Giheung-gu, Yongin-si, Gyeonggi-do, South Korea
- Website
- www.neolens.co.kr
- [email protected]
- Phone
- +82-31-627-5507
- PRRC contact
- Jonggil Jang
FDA establishments
- Neovision Corp. US
Frequently asked questions
How many devices does NEO VISION CO. LTD have in the registry?
The registry currently lists 4 devices for NEO VISION CO. LTD. Devices recorded under merged duplicate company entries are counted once.
Which registries list NEO VISION CO. LTD's devices?
Among its 4 most recently registered devices, NEO VISION CO. LTD has devices listed in EUDAMED (4 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do NEO VISION CO. LTD's devices fall under?
Among its 4 most recently registered devices, the classes recorded for NEO VISION CO. LTD's devices are Class IIa and Class IIb. Each device page shows its own class and authorisation.
What are the newest devices from NEO VISION CO. LTD in the registry?
The most recently registered devices listed for NEO VISION CO. LTD include MAXLOOK 60ml, MAXLOOK 360ml, NEO PLUS GOLD and NEO COSMO.
Which FDA establishments are linked to NEO VISION CO. LTD?
1 FDA establishment is linked to NEO VISION CO. LTD in the registry; they are listed on the company page.